This study will hypothesize that the use of a self fixating lightweight mesh in open inguinal repair is feasible in the Philippine setting. It will result in a comparable recurrence rate as published for the traditional Lichtenstein approach.

Further study details as provided by De La Salle University Medical Center:

Estimated Enrollment:

100

Study Start Date:

September 2011

Estimated Study Completion Date:

December 2014

Estimated Primary Completion Date:

October 2014 (Final data collection date for primary outcome measure)

Detailed Description:

The specific aim of this study is to assess the feasibility of using a self fixating lightweight mesh in open inguinal hernia under both under regional and local anesthesia in the Philippines. The primary endpoint of which is to assess the recurrence rate at 2 years (with an interim analysis 1 year after the procedure). Secondary endpoints would be to gather data with regards to postoperative pain, post operative surgical complications, wound healing complications, operating factors (mesh deployment time, total operating time), hernia factors (type and size of inguinal hernia).

Eligibility

Ages Eligible for Study:

18 Years to 80 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Sampling Method:

Probability Sample

Study Population

Potential study subjects will be patients who are:

18 - 80 years old; Has confirmed with the informed consent; Has a primary inguinal hernia (either unilateral or bilateral) which is reducible and amenable to local or regional hernia repair

Criteria

Inclusion Criteria:

Age 18-80 years

Informed consent

Primary inguinal hernia suitable for open inguinal repair

Reducible hernia

Exclusion Criteria:

Incarcerated non reducible hernias

Bleeding disorders

Patients below 18 (lower age limit) and above 80 (upper age limit) years old

Hernia defects of greater than 4 cm

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01421602